HYDROCORTISONE CREAM- hydrocortisone cream

Hydrocortisone Cream by

Drug Labeling and Warnings

Hydrocortisone Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

• for external use only
• avoid contact with eyes
• do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

• do not exceed the recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly
• children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

Stop using this product and ask a doctor

• in case of bleeding
• if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

• If you have a vaginal discharge
• before treating diaper rash
• before using on children under 2 years of age

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
• children under 12 years of age: do not use, consult a doctor

Inactive Ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate

Other Information

• to open; unscrew cap and pull tab to remove foil seal
• if seal has been broken, do not use this product. Return product to the store where you bought it
• store at controlled room temperature 15°-30°C (59°-86°F)
• see carton or tube crimp for lot number and expiration date

Other Information

Distributed By:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

1-888-296-9067

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-028-01	1 in 1 BOX	04/07/2017
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-028-02	1 in 1 BOX	04/07/2017
2		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/07/2017

Labeler - Trifecta Pharmaceuticals USA (079424163)